What is the recommended treatment regimen for hepatitis C using Epclusa (sofosbuvir and velpatasvir)?

Epclusa (Sofosbuvir/Velpatasvir) Treatment Regimen for Hepatitis C

For patients with chronic hepatitis C infection (genotypes 1-6), the recommended treatment regimen is sofosbuvir/velpatasvir (Epclusa) 400mg/100mg taken once daily for 12 weeks, regardless of prior treatment experience or compensated cirrhosis status. 1

Treatment Recommendations by Patient Population

Standard Treatment

• Dosage: One tablet (400 mg sofosbuvir/100 mg velpatasvir) taken orally once daily with or without food 1
• Duration: 12 weeks 1
• Patient population: Adults and pediatric patients 3 years and older with chronic HCV genotypes 1-6 1
• Applicable to:
  • Treatment-naïve patients
  • Treatment-experienced patients
  • Patients without cirrhosis
  • Patients with compensated cirrhosis (Child-Pugh A)

Special Populations

Decompensated Cirrhosis

• Regimen: Sofosbuvir/velpatasvir + ribavirin for 12 weeks 1
• Ribavirin dosing: Weight-based (1,000 mg daily for patients <75 kg and 1,200 mg daily for patients ≥75 kg) 2

Liver Transplant Recipients

• For treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), the recommended regimen is sofosbuvir/velpatasvir once daily for 12 weeks 1

HCV/HIV Co-infection

• Follow the same dosage recommendations as for HCV mono-infection 1

Pediatric Patients

• For children 3 years and older: Weight-based dosing 1
• For children under 6 years: Administer oral pellets with food 1

Pre-treatment Assessment

1. HBV Testing: Test all patients for HBV infection by measuring HBsAg and anti-HBc before starting treatment 1

   • Warning: HBV reactivation has been reported, sometimes resulting in fulminant hepatitis, hepatic failure, and death

2. Drug Interaction Screening:

   • Avoid coadministration with amiodarone due to risk of serious symptomatic bradycardia 1
   • Check for interactions with proton pump inhibitors 2
   • Assess for interactions with antiretroviral medications in HIV co-infected patients 2

Monitoring During Treatment

• No routine HCV RNA monitoring is required during treatment 2
• Monitor for adverse effects:
  • Most common adverse reactions (≥10%): headache and fatigue in adults and children ≥6 years 1
  • In children <6 years: vomiting and spitting up the drug 1
• Patients with cirrhosis require closer monitoring for signs of decompensation 2
• For HBV/HCV co-infected patients: Monitor for HBV reactivation and hepatitis flare during and after treatment 1

Post-Treatment Follow-up

• HCV RNA testing at 12 weeks post-treatment to confirm sustained virological response (SVR12) 2

Clinical Efficacy

Sofosbuvir/velpatasvir has demonstrated high efficacy across all HCV genotypes:

• In the ASTRAL-1 trial, SVR12 rates of 97-100% were achieved in patients with genotypes 5 and 6 3
• Phase 3 trials showed SVR rates of 96-99% in treatment-naïve patients without cirrhosis 2
• Even in difficult-to-treat populations like those with genotype 3 and compensated cirrhosis, SVR rates of 88-96% have been reported 4

Advantages of Sofosbuvir/Velpatasvir

1. Pangenotypic coverage: Effective against all HCV genotypes (1-6) 1
2. Single tablet regimen: Improves adherence 5
3. Ribavirin-free for most patients: Except those with decompensated cirrhosis 1
4. Improved patient-reported outcomes: Significant improvements in quality of life metrics during and after treatment 6

Important Caveats

• Lower efficacy may be observed in patients with HCV genotype 3b and cirrhosis (50% SVR12) 7
• Resistance-associated substitutions in NS5A may affect treatment response in certain populations 7
• Contraindicated with amiodarone due to risk of serious bradycardia 1
• When used with ribavirin, all ribavirin contraindications apply 1

Sofosbuvir/velpatasvir represents a highly effective, well-tolerated treatment option for chronic HCV infection with the convenience of a once-daily, single-tablet regimen suitable for nearly all patient populations.